Premier Research, Austin, TX, USA Worldwide Clinical Trials, Nottingham, UK Reckitt Benckiser Healthcare UK Ltd, Hull, UK Clearcut Clinical Consulting, Nottingham, UK.
Pain. 2011 Mar;152(3):632-642. doi: 10.1016/j.pain.2010.12.012. Epub 2011 Jan 22.
Combination analgesia is often recommended for the relief of severe pain. This was a double-blind, 5-arm, parallel-group, placebo-controlled, randomised, single-dose study designed to compare the efficacy and tolerability of a novel single-tablet combination of ibuprofen and paracetamol with that of an ibuprofen/codeine combination, and a paracetamol/codeine combination, using the dental impaction pain model. Subjects with at least 3 impacted third molars and experiencing moderate to severe postoperative pain were randomised to receive: 1 or 2 tablets of a single-tablet combination of ibuprofen 200mg/paracetamol 500mg; 2 tablets of ibuprofen 200 mg/codeine 12.8mg; 2 tablets of paracetamol 500mg/codeine 15mg; or placebo. Results for the primary endpoint, the sum of the mean scores of pain relief combined with pain intensity differences over 12hours, demonstrated that 1 and 2 tablets of the single-tablet combination of ibuprofen/paracetamol were statistically significantly more efficacious than 2 tablets of placebo (P<0.0001) and paracetamol/codeine (P⩽0.0001); furthermore, 2 tablets offered significantly superior pain relief to ibuprofen/codeine (P=0.0001), and 1 tablet was found noninferior to this combination. Adverse events were uncommon during this study and treatment emergent adverse events were statistically significantly less frequent in the groups taking the ibuprofen/paracetamol combination compared with codeine combinations. In conclusion, 1 or 2 tablets of a single-tablet combination of ibuprofen 200mg/paracetamol 500mg provided highly effective analgesia that was comparable with, or superior to, other combination analgesics currently indicated for strong pain. A single-tablet combination of ibuprofen 200mg/paracetamol 500mg provides highly effective analgesia, comparable or superior to other combination analgesics indicated for strong pain.
联合镇痛通常被推荐用于缓解严重疼痛。这是一项双盲、5 臂、平行组、安慰剂对照、随机、单次剂量研究，旨在比较新型布洛芬和对乙酰氨基酚单片复方与布洛芬/可待因复方和对乙酰氨基酚/可待因复方在牙阻生疼痛模型中的疗效和耐受性。至少有 3 颗阻生第三磨牙且经历中度至重度术后疼痛的受试者被随机分配接受以下治疗：1 或 2 片布洛芬 200mg/对乙酰氨基酚 500mg 的单片复方；2 片布洛芬 200mg/可待因 12.8mg；2 片对乙酰氨基酚 500mg/可待因 15mg；或安慰剂。主要终点（12 小时内疼痛缓解评分总和与疼痛强度差异）的结果表明，1 片和 2 片布洛芬/对乙酰氨基酚单片复方在统计学上显著优于 2 片安慰剂（P<0.0001）和对乙酰氨基酚/可待因（P⩽0.0001）；此外，2 片的止痛效果显著优于布洛芬/可待因（P=0.0001），而 1 片与该联合用药相比非劣效。在这项研究中，不良事件并不常见，接受布洛芬/对乙酰氨基酚联合用药的组发生治疗突发不良事件的频率在统计学上显著低于接受可待因联合用药的组。总之，1 片或 2 片布洛芬 200mg/对乙酰氨基酚 500mg 单片复方提供了高度有效的镇痛作用，与其他目前用于强烈疼痛的联合镇痛药相当或优于其他联合镇痛药。布洛芬 200mg/对乙酰氨基酚 500mg 单片复方提供了高度有效的镇痛作用，与其他用于强烈疼痛的联合镇痛药相当或优于其他联合镇痛药。
